Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery

• Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  

• Repair breakdown one week following catheter removal [ Time Frame: 14 days or 21 days post-repair ] [ Designated as safety issue: Yes ]
  
• Intermittent catheterization due to urinary retention [ Time Frame: 7 or 14 days post repair ] [ Designated as safety issue: Yes ]
  
• Prolonged hospitalization [ Time Frame: 14 or 21 days post-repair ] [ Designated as safety issue: No ]
  
• Catheter blockage [ Time Frame: 14 or 21 days post repair ] [ Designated as safety issue: Yes ]
  
• Self-reported residual incontinence [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  
• The occurrence of septic or febrile episodes [ Time Frame: 14 or 21 days post-repair ] [ Designated as safety issue: Yes ]
  

A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity (by freeing available bed space and increasing availability of nursing staff), lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery.

This facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test, a routine practice in fistula repair services. t. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization (defined as a stay at the facility beyond one week following initial catheter removal related to an adverse event), catheter blockage, and self-reported residual incontinence. This study will be conducted among 507 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 16-18 months at each site.